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Sponsors and Collaborators: |
Spanish Cooperative Group for Gastrointestinal Tumour Therapy Merck Sanofi-Aventis |
Information provided by: | Spanish Cooperative Group for Gastrointestinal Tumour Therapy |
ClinicalTrials.gov Identifier: | NCT00733889 |
The purpose of the study is to determine efficacy ans safety of the combination of cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) as neoadjuvant therapy followed concomitant chemoradiotherapy (cisplatin) plus cetuximab in patients with a locoregional esophageal carcinoma
Condition | Intervention | Phase |
Esophageal Carcinoma |
Drug: cetuximab and chemotherapy (docetaxel, cisplatin, 5-fluorouracil) |
Phase II |
MedlinePlus related topics: | Cancer Esophageal Cancer Esophagus Disorders |
ChemIDplus related topics: | Docetaxel Cisplatin Fluorouracil Cetuximab |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II, Multicentre, Uncontrolled Pilot Study to Evaluate Safety and Efficacy of the Combination of Cetuximab and Chemotherapy (Docetaxel, Cisplatin, 5-Fluorouracil) as Neoadjuvant Therapy Followed Concomitant Chemoradiotherapy (Cisplatin) Plus Cetuximab in Patients With a Locoregional Esophageal Carcinoma |
Estimated Enrollment: | 45 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | September 2010 |
Estimated Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
Neoadjuvant chemotherapy plus cetuximab:
3 cycles of chemotherapy (Docetaxel: 75 mg/m2; day1; Cisplatin :75 mg/m2, day 1; 5-FU: 750 mg/m2; 24-hour infusion; day1-5) administered every 3 weeks, plus cetuximab (250 mg/m2; day 1, 8 and 15) Cetuximab will be maintained from the beginning of chemotherapy until the end of radiotherapy.
Radio-chemotherapy plus cetuximab:
The radiotherapy treatment: A dose of 50.4 Gy will be administered in 28 fractions of 1.8 Gy / day, 5 days a week (a total of 5.6 weeks).
Cetuximab:250 mg/m2 and Cisplatin: 40 mg/m2, day 1, 8, 15, 22, 29 and 36
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Inmaculada Ruiz de Mena, phD | 00 34 91 378 82 75 | ttd@ttdgroup.org |
Spain | |||||
Spanish Cooperative Group for Gastrointestinal Tumour Therapy | Recruiting | ||||
Madrid, Spain, 28046 |
Spanish Cooperative Group for Gastrointestinal Tumour Therapy |
Merck |
Sanofi-Aventis |
Study Chair: | Josep Tabernero, MD; phD | Medical Oncology Department; Hospital Universitario Vall d'Hebrón; Barcelona |
Study Chair: | Jordi Giralt, MD; phD | Oncology Radiation Department; Hospital Universitario Vall d'Hebrón; Barcelona |
Responsible Party: | Spanish Cooperative Group for Gastrointestinal Tumour Therapy ( Spanish Cooperative Group for Gastrointestinal Tumour Therapy ) |
Study ID Numbers: | TTD-06-02, EudraCT number:2006-001880-42 |
First Received: | August 12, 2008 |
Last Updated: | August 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00733889 |
Health Authority: | Spain: Spanish Agency of Medicines |
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